Validation And Qualification In Analytical Laboratories

This complete guide and reference explains how to improve product quality while achieving compliance with the world's regulatory standards. It shows how to develop and implement a validation strategy for routine, nonroutine, and standard analytical methods encompassing the entire equipment hardware and software qualification process. It includes examples and templates to help readers through the validation process. In addition to guidelines on the qualification of standards, certified and in-house reference materials, and employee qualification, it covers internal and third-party lab audits and inspections.